Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT01584258 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Prostate Advances in Comparative Evidence

Study acronym: PACE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 19, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Sep 2021 to Dec 2025v10 Show 10 more changesShow less
    • Start date: Apr 2012 to Aug 7, 2012
    • Primary endpoints: 1 to 2
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1716 to confirmed 2205
    • Study sites: 2 to 68
    • Study completion date: Sep 2026 to Dec 2027
    • Interventions: Conventionally Fractionated Prostate Radiotherapy (Radiation), Laproscopic Prostatectomy (Procedure), Prostate SBRT (Radiation) to Conventionally Fractionated Prostate Radiotherapy (Radiation), Prostate SBRT (Radiation), Prostatectomy (Procedure)
    • Eligibility criteria expanded, about 175 words
    • Secondary endpoints: 6 to 7
    • Study arms: 2 to 3
  2. Interventions: Conventionally Fractionated Prostate Radiotherapy (Radiation), Laproscopic prostatectomy (Procedure), Prostate SBRT (Radiation) to Conventionally Fractionated Prostate Radiotherapy (Radiation), Laproscopic Prostatectomy (Procedure), Prostate SBRT (Radiation)v9
  3. Interventions: Conventionally Fractionated Prostate Radiotherapy (Radiation), Laproscopic or da vinci prostatectomy (Procedure), Prostate SBRT (Radiation) to Conventionally Fractionated Prostate Radiotherapy (Radiation), Laproscopic prostatectomy (Procedure), Prostate SBRT (Radiation)v8
  4. Primary endpoint revisedv7 Show 5 more changesShow less
    • Study sites: 1 to 2
    • Interventions: CyberKnife prostate SBRT delivered by the CyberKnife in 36.25Gy in 5 fractions or 38Gy in 4 fractions (Other) to Conventionally Fractionated Prostate Radiotherapy (Radiation), Laproscopic or da vinci prostatectomy (Procedure), Prostate SBRT (Radiation)
    • Eligibility criteria expanded, about 60 words
    • Secondary endpoints: 4 to 6
    • Collaborators: 5 to 1
  5. Lead sponsor: Accuray Incorporated to Royal Marsden NHS Foundation Trustv6 Show 6 more changesShow less
    • Trial status: Terminated to Recruiting
    • Enrollment target: 136 to 1716
    • Primary completion date: Jun 2014 to Sep 2021
    • Study completion date: Jun 2014 to Sep 2026
    • Site details revised
    • Collaborators: 6 to 5
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Recruiting to Terminated Sponsor's reason: Study sponsorship has transitioned to the Royal Marsden (UK).v5 Show 4 more changesShow less
    • Enrollment target: estimated 1036 to confirmed 136
    • Primary completion date changed from estimate of Apr 2020 to Jun 2014
    • Study completion date changed from estimate of Apr 2025 to Jun 2014
    • Site details revised
  2. 2 versions Re-verified since Sep 17, 2012, no change to tracked fieldsv3-v4
  3. Collaborators: 5 to 6v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.
Trial Details
NCT Number NCT01584258
Lead Sponsor Royal Marsden NHS Foundation Trust
Collaborators: The Institute of Cancer Research, Sutton, Surrey, UK
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 2,205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov